With the development of China’s 5G network, the smart healthcare industry has also been further advanced and developed, and the demand about intelligent medical devices is continuing to rise. The intelligent software medical devices as well as the AI medical device products need to submit the application for the medical device sole registration certificate to National Medical Products Administration （NMPA  or Provincial MPA) before to be marketed. Although intelligent software medical devices is part of a medical device, some of the regulations are different. How does a medical device standalone software registration application work? What problems may be encountered? For more detailed information, please contact us.

New Registration

1.Application form

(1) Independent Software

The product name shall conform to the requirements of the general name naming specification for independent software, usually reflecting the input data, core functions, intended use and other characteristic words.

The model specification indicates the software release version without reflecting the English abbreviation V of the version.

The structural composition specifies the delivery content and functional modules, of which the delivery content includes software program files such as software installation program, authorization file, external software environment installation program, etc. The functional modules include client-side, server-side (if applicable), and cloud-side (if applicable), and if applicable, it specifies the options and module versions.

The scope of application is usually standardized based on the intended use, usage scenarios, core functions, and if applicable, the scope of application of each functional module is described. At the same time to ensure the standardization of terms, distinguish between “analysis” and “measurement”, “surgical simulation” and “surgical planning”, use “analysis” and “measurement”. “and use the terms “display” and “receive” instead of “browse” and “capture”.

 

(2) Software components

Software components are usually not required to be reflected in the information contained in the registration certificate. The names of software functions can be referred to the requirements for intelligent software. Structural components to ensure the standardization of terminology, the use of “host computer”, “workstation” rather than “computer”, “computer”, “computer”. “. If there are decision-aiding software functions, the structure (if applicable) and scope of application should be reflected.

For cases where specialized intelligent software is regarded as a software component, the name of the software shall be the same as that of the intelligent software, the structural composition of the software shall specify the name of the software, the model specification, and the release version, and the scope of application shall reflect the functions of the decision-supporting software.

 

2.Software research information

Submit self-research software research report, external software environment assessment report (if applicable) and GB/T 25000.51 self-test report.

If off-the-shelf software components are used, submit the appropriate study information according to the way they are used.

In addition, it is encouraged to submit marketing materials for medical device products in the software research data. This material is only used as a review reference material to supplement product information, not as the subject of review, and not as the basis for review decision-making.

 

3.Product technical requirements(PTR)

(1) Independent software

Intelligent software product technical requirements “product model / specification and its division description” to clarify the name of the software, model specifications, release version, version naming rules, software modules (including medical middleware), if there is a separate version, version naming rules need to be explained.

“Performance indicators” include general requirements, special requirements, safety requirements, of which the general requirements according to the software product characteristics of the specification, inapplicable content in the non-clinical information to be explained in the chapter of technical requirements of the product; special requirements in line with the relevant product standards (such as radiation treatment planning software) requirements, safety requirements in line with the relevant safety standards (such as alarms, radiation therapy) requirements. The safety requirements are in accordance with the relevant safety standards (e.g., alarm, radiation therapy).

The “Appendix” provides architecture diagrams, user interface relationship diagrams and main interface diagrams, physical topology diagrams and necessary comments.

 

(2) Software components

Software components are standardized in the product technical requirements of the medical device, of which “product model / specification and its division of instructions” to clarify the name of the software, model specifications (if applicable), release version, version naming rules, software modules (including medical middleware), if there is a separate version of the version, version naming rules need to be explained.

“Performance indicators” include the software’s functionality, usage restrictions, interfaces, access control, operating environment (if applicable), performance efficiency (if applicable) and other requirements. Among them, the function specifies the outline of all core functions of the software (including safety functions), indicating the optional and automatic functions, of which the objective physical measurement function specifies the measurement accuracy indexes, the data resources (such as reference database) specifies the types of data and the sample size of each type of data, and the core algorithms are to be noted if the core functions are the same but the core algorithms are different; the use restriction includes the user’s use restriction and the technical restriction; Interfaces, including application interfaces, data interfaces, product interfaces for users to call; access control to clarify the software user identity identification methods, user types and user access rights; operating environment, performance efficiency applies to external control software components, specialized independent software is considered as a software component, where the operating environment (including cloud computing) to clarify the typical configuration, including the hardware configuration, the external software environment, network conditions, and the performance efficiency of the software in a typical operating environment. Performance efficiency clear software in a typical operating environment to complete the typical core functions of the time characteristics, if applicable clear resource utilization, capacity. The inapplicability of the above terms is explained in the non-clinical information.

For specialized intelligent software to be considered as a software component, in addition to the above requirements for software components, an architecture diagram, a user interface relationship diagram and a main interface diagram, a physical topology diagram, and the necessary annotations should also be provided in the “Appendix”.

 

4. Instruction for use(IFU)

IFU should meet the requirements of relevant laws and regulations, normative documents, national standards and industry standards.

IFU need to reflect the software features, use restrictions, input and output data types, necessary hardware and software, the maximum number of concurrency, interface, access control, operating environment (if applicable), performance and efficiency (if applicable) and other information, clear software release version.

Among them, the software functions include all core functions (including security functions), indicating the optional, automatic functions, in which the measurement function specifies the measurement accuracy indexes, the graphical measurement function is also required to provide warning information on the accuracy of the measurement, and the data resource specifies the types of data and the sample size of each type of data. Interface item by item description of each software interface for the user to call the expected user, the use of the scene, the expected use, technical characteristics, use restrictions, failure countermeasures. Operating environment (including cloud computing), performance efficiency applies to independent software, external control type software components, specialized independent software is regarded as a software component, the specific requirements are detailed in the previous section.

If applicable, inform the user that the general-purpose computing platform meets the safety requirements for information technology equipment (including electromagnetic compatibility), and list the corresponding standards.

 

5. Sample labeling (for intelligent software)

For physical delivery, the product labeling shall comply with the appropriate regulations. For web-based delivery, submit a photo of the web-based delivery page of the product, where the product registration information should comply with the corresponding regulations.

In addition, it is recommended that the product registration information be reflected in the software user interface such as “About” or “Help”.

 

Change Registration

1.Software research information

Medical device change registration should be based on the software update, submit the software change part of the product safety and effectiveness of the impact of research information:

(1) Involving the perfect software update: applicable to self-developed software to occur perfect update, or combined adaptive update, corrective update, this time to submit the self-developed software to update the perfect research report (or self-research software research report), the external software environment assessment report (if applicable), and GB/T 25000.51 self-test report;

(2) Involving adaptive software updates: Applicable to adaptive updates of self-research software, or combined corrective updates, but not the case of perfect updates, then submit the self-research software adaptive update research report (or self-research software research report);

(3) Only corrective software updates: For cases where only corrective updates to the self-research software occur, the study report on corrective updates to the self-research software is submitted at this time;

(4) No software updates have occurred: a statement of authenticity is issued, clearly assuming legal responsibility.

If you use ready-made software components, submit the corresponding research information according to the way of its use. See Chapter 8 for details of the requirements for the relevant study materials.

If applicable, it is encouraged to submit marketing materials for medical device products in the software study data. This material is only used as a reference material to supplement the product information, not as the subject of review, and not as the basis for review decisions.

 

2. Product technical requirements

(1) Independent software

Independent software product technical requirements reflect software updates, including “product model / specification and its division of the description”, “performance indicators”, “Appendix”.

 

(2) Software components

Software components in the product of medical devices belonging to the technical requirements of software updates, including “product model / specification and its division” of the software information, “performance indicators” of the software requirements.

Specialized independent software is considered a software component of the same requirements and software components.

 

3. Instruction for use

If applicable, submit a description of the changes in IFU.

 

4. Product labeling samples ( independent software )

If applicable, submit the product labeling samples of the declared product and its changes.

 

Renewal Registration

Renewal registration normally does not require the submission of software-related research data. If applicable, according to the requirements set out in the “Remarks” of the registration certificate to submit the corresponding software research data.

Product technical requirements “product model / specification and its division description” clear software name, model specifications, release version, version naming rules, if the original registered product standards (or the original product technical requirements) and its change of the comparison table does not reflect the above software information, need to be clarified in the Declaration of Conformity.

Independent software product technical requirements “performance indicators”, “test methods” do not need to be modified in accordance with the requirements of the appendix to this guideline, should be consistent with the original registered product standards (or the original product technical requirements) and its changes in the comparison table, and the “performance indicators”. The relevant clauses of “Performance Indicators” should be deleted from the information already contained in the registration certificate.

 

Relevant laws and regulations involved in medical device independent software registration

When applying for medical device independent software registration, you need to follow a series of laws and regulations, including but not limited to

It should be noted that pay attention to the latest regulatory developments when applying for registration.

 

Commonly Asked Questions for Medical Device Independent Software Registration

In the process of applying for medical device independent software registration, you may encounter some problems, the following are some answers to frequently asked questions:

Q1:How to develop performance indicators for independent software, and what needs to be included in the inspection report?

A:Independent software can directly refer to the template in Appendix I of the Guiding Principles for Technical Review of Medical Device Software Registration for the preparation of product technical requirements. For medical image storage and transmission software (PACS), it is also necessary to specify the consistency and integrity of image data after image transmission, the time to open the image (including the time of image transmission and display) under specified test conditions, and the test conditions should specify whether the network environment is a stand-alone computer, a local area network (LAN) or a wide area network (WAN).

Expected to be used for diagnosis of mobile image processing software, according to the “Guiding Principles for the Technical Review of Mobile Medical Device Registration”, the product technical requirements to develop a function with data unavailability, product registration information user confirmation function, the operating environment power-on self-test function, ambient light detection function, display brightness correction function and other performance indicators.

Independent software inspection report also needs to include the full version of the software and software release version of the interface photos. If there are multiple operating environments or multiple release versions, each incompatible operating environment or each release version that does not cover each other should be treated as a testing unit. For example, the operating system software contains Windows and iOS, the inspection report needs to be tested separately. For Web browsers, the supported mutually incompatible browsers (e.g., IE, Chrome, Firefox, etc.) should be treated as a separate unit of detection.

 

Q2:Software description of how to prepare documents, software research data need to pay attention to what issues?

A:The software description document is prepared according to the requirements of “Table 1 Software Description Document Framework” of “Guiding Principles for Technical Review of Medical Device Software Registration”. For example, software safety level B products, in addition to the body of the software description document, generally include the following attachments: software requirements specification in full; software development life cycle plan, configuration management plan and the summary of the maintenance plan; system testing, user testing plans and reports.

In addition, a statement of authenticity of the naming rules of the software version is also required to be issued, specifying all the fields of the software version and the meanings of the fields, and confirming the full version of the software and the software release version.

If the applicant claims that the product complies with the DICOM standard, it should provide the DICOM compliance statement, and the method and content of the DICOM compliance statement should refer to the relevant provisions in the DICOM standard.

If the applicant claims that the product complies with HL7 standard, it should provide HL7 compliance statement, and the method and content of HL7 compliance statement should refer to the relevant provisions in HL7 standard.

 

Q3:Medical device independent software version regulations

A:Product technical requirements should be clear in the product software version of the naming rules, release version.

The release version of the product software should be specified in the product specification.

In the declaration of conformity of the product has not changed part of the clear product software and off-the-shelf software (if applicable) version naming rules, the full version and release version.

 

Q4:Medical device independent software update issues

A:If the product involves significant software updates, that is, software updates affect the intended use of medical devices, the use of the environment or core functions (such as changes in operating systems, changes in clinical functions, changes in software output results, changes in user habits, changes affecting patient safety, etc.), should be processed to change registration, the registrant should submit the renewal registration application after get the approval of the original approval department.